Prospective Study of Clinically Nonfunctioning Pituitary Adenomas (PAPS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Columbia University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Pamela U. Freda, Columbia University
ClinicalTrials.gov Identifier:
NCT01556230
First received: March 9, 2012
Last updated: May 13, 2015
Last verified: May 2015
  Purpose

This project is the first comprehensive prospective study of clinically non-functioning pituitary adenomas (CNFAs). Two groups of subjects will be studied. Group I will consist of 100 patients CNF pituitary lesions who are asymptomatic and do not require surgery. Group II will consist of 250 patients who have pituitary lesions that are symptomatic and require surgery. Patients will be followed with a series of endocrine laboratory testing, physical examinations, testing of quality of life and neurocognitive function before and serially over time either during non surgical management or after surgery and in some patients before and after RT. Data on pituitary MRI studies and visual field testing being done over time during follow up as part of clinical care will be collected.


Condition Intervention
Pituitary Adenoma
Pituitary Tumor
Procedure: Surgical intervention for CNFA
Radiation: Radiotherapy for CNFA

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study of Clinically Nonfunctioning Pituitary Adenomas

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Number of patients with pituitary tumor enlargement [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Tumor enlargement over the study period


Secondary Outcome Measures:
  • Change in neurocognitive function test score [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Neurocognitive function change over the time frame of the study


Biospecimen Retention:   Samples Without DNA

Blood Serum and Plasma samples


Estimated Enrollment: 350
Study Start Date: November 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group I
The first group of subjects, Group I, will be followed in Protocol I and are a group of subjects with an apparent clinically nonfunctioning pituitary lesion who will be studied in a prospective study of conservative non-surgical management.
Group II
A second group of subjects, Group II, are subjects who are undergoing surgical intervention for CNFA or radiotherapy for CNFA and these subjects will be studied in a prospectively follow up as part of Protocol II.
Procedure: Surgical intervention for CNFA
(non-experimental) standard procedure
Radiation: Radiotherapy for CNFA
(non-experimental) standard procedure

Detailed Description:

PROTOCOL I: Prospective Study of the outcome of conservative non-surgical management of patients with asymptomatic, clinically non-functioning pituitary lesions. This protocol will evaluate prospectively the outcome of non-surgical management of clinically non-functioning pituitary lesions that do not appear to need surgery as their initial therapy. The overall design consists of an initial baseline evaluation and then serial prospective follow up studies over time for up to 5 years of follow up. The study will evaluate laboratory testing, clinical examinations, quality of life and neurocognitive function in these patients. We will also collect data on visual fields and MRI studies of the pituitary tumor that are done prospectively as part of clinical care to evaluate these patients. Data to be collected will include the prevalence of pituitary dysfunction at presentation, the safety of conservative non-surgical management of patients with asymptomatic, clinically nonfunctioning pituitary lesions with respect to the development of symptomatic tumor enlargement and pituitary dysfunction, the prevalence of the silent corticotroph tumor type that is characterized by elevated plasma levels of ACTH or its precursor, POMC, and if it is associated with an increased tumor recurrence rate and prospectively assess quality of life and neurocognitive function in patients with clinically non-functioning pituitary lesions treated without surgery.

PROTOCOL II : Prospective study of the outcome of patients with symptomatic, clinically non-functioning pituitary tumors who are treated with transsphenoidal surgery and in some cases also radiotherapy. This protocol will evaluate prospectively the outcome of surgical management of asymptomatic clinically nonfunctioning pituitary lesions. The overall design consists of an initial baseline evaluation and then serial prospective follow up studies over time with up to 5 years of follow up. The study will evaluate laboratory testing, clinical examinations, quality of life and neurocognitive function in these patients. We will also collect data on visual fields and MRI studies of the pituitary tumor that are done prospectively as part of clinical care to evaluate these patients. Data to be collected will be analyzed to determine the safety of observation alone following surgery for patients who do not have a clinically significant tumor remnant, if the silent corticotroph tumor type is characterized by elevated plasma levels of ACTH or its precursor, POMC, and if it is associated with an increased tumor recurrence rate. A group of patients who are planning RT will also be studied by these same procedures before and after RT in order to determine if the outcomes of patients who receive RT for treatment of tumor re-growth to that of those who do not receive RT with respect to further tumor growth, endocrine or neurological dysfunction. We will also prospectively assess quality of life and neurocognitive function in patients with clinically non-functioning pituitary lesions treated with surgery alone or those who also receive radiotherapy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Any persons diagnosed with a non-functioning pituitary adenoma that is willing to travel to our study center at Columbia University in New York, NY for all study visits.

Criteria

GROUP I

Inclusion Criteria:

  • adult patients with pituitary lesions that do not require surgical intervention.
  • pituitary lesion that has been demonstrated on a MRI to be consistent with an adenoma (not a cystic lesion such as a Rathke's cleft cyst).
  • patients with macroadenomas (> 1 cm) or large microadenomas 6-9 mm.
  • a prolactin level < 40 ng/ml.

Exclusion Criteria:

  • presence of visual or neurological deficits due to the tumor, tumor impingement on the optic chiasm and physical or laboratory abnormalities consistent with a biologically active hormone secreting tumor.

GROUP II

Inclusion Criteria:

  • adult patients with pituitary lesions that require surgical intervention and are planning on surgery or who had surgery in the past and are now undergoing pituitary radiotherapy.
  • pre-surgery patients will have a pituitary lesion that has been demonstrated on a MRI to be consistent with an adenoma (not a cystic lesion such as a Rathke's cleft cyst) and that is a macroadenoma (> 1 cm).
  • presence of visual or neurological deficits due to the tumor or impingement of the tumor on the optic chiasm is permitted.
  • a prolactin level < 100 ng/ml if lesion is > or = 10 mm in size or a prolactin level < 40 ng/ml if lesion is < 10 mm in size.
  • patients with mild/moderate hyperprolactinemia and recommended for dopamine agonist therapy (on the chance that the lesion is truly a prolactinoma) may re-enter the study should they be a dopamine agonist failure and require surgery.
  • patients with hypopituitarism and no other surgical indication that choose to undergo surgery is permitted.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01556230

Contacts
Contact: Carlos M Reyes-Vidal, MD 212-305-4921 csr52@cumc.columbia.edu
Contact: Jean Carlos Fernandez, MD 212-305-4921 sjf2132@columbia.edu

Locations
United States, New York
Columbia University College of Physicians & Surgeons Recruiting
New York, New York, United States, 10032
Contact: Carlos M Reyes-Vidal, MD    212-305-4921    csr52@cumc.columbia.edu   
Contact: Jean Carlos Fernandez, MD    212-305-4921    sjf2132@cumc.columbia.edu   
Principal Investigator: Pamela U. Freda, MD         
Sub-Investigator: Sharon L Wardlaw, MD         
Sub-Investigator: Jeffrey N Bruce, MD         
Sub-Investigator: Steven R Isaacson, MD         
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Pamela U. Freda, MD Columbia University College of Physicians&Surgeons
  More Information

No publications provided

Responsible Party: Pamela U. Freda, Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT01556230     History of Changes
Other Study ID Numbers: AAAE1260, R01NS070600
Study First Received: March 9, 2012
Last Updated: May 13, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
pituitary gland
pituitary adenoma
pituitary tumor
hypophysis
endocrine
neuroendocrine
hormone

Additional relevant MeSH terms:
Pituitary Diseases
Pituitary Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Endocrine Gland Neoplasms
Hypothalamic Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Nervous System Neoplasms
Supratentorial Neoplasms
Adenoma
Brain Diseases
Central Nervous System Diseases
Endocrine System Diseases
Hypothalamic Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 21, 2015